Agency classClass IIOur severity:High FDA (Devices)·Z-1100-2019·Announced 2019-04-17

Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Inter-Lumen Leak

Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to a reported leak between the cardioplegia and pressure lumens.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a critical medical device used during cardiac procedures. While no specific injuries are detailed in the provided text, the risk of harm from a malfunctioning device in a high-risk clinical setting aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Edwards Lifesciences, LLC is recalling the IntraClude Intra-Aortic Occlusion Device. This medical device is a 10.5 Fr, triple lumen catheter with an elastomeric balloon designed to occlude the ascending aorta to partition the aortic root from arterial circulation. The recall involves 2,715 units that were distributed worldwide, including the United States and various countries in Europe, the Middle East, and Asia.

The recall was initiated after Edwards Lifesciences received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and the pressure lumen. The device is used to deliver cardioplegia solution to the aortic root and monitor aortic root pressure. The leak compromises the device's ability to perform these functions safely and effectively.

Healthcare providers and facilities that have received these devices should stop using them and contact Edwards Lifesciences for further instructions. The specific lot codes affected are listed in the agency's recall record.

The recalled product

Product: Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial…
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Cardiac Catheter
Hazard: device-malfunction
leak
Affected units: 2,715

Distribution

Distributed nationwide across the United States.

Same manufacturer · Edwards Lifesciences, LLC

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